FDA.reportPublic FDA data

LifeShield Infusion Safety Software Suite

Primary DI
00887709127227
Brand
LifeShield Infusion Safety Software Suite
Company
ICU Medical, Inc.
Model
17003-02
Device description
GTIN for 17003-02, 1/EA
Published
2025-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PHCInfusion safety management software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHCInfusion Safety Management SoftwareGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242117000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242117000LifeShield Infusion Safety Software SuiteIcu Medical, Inc.2025-04-02PHC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887709127227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887709127227008877091272278877091272270887709127227

GMDN Terms#

Term, Definition table
TermDefinition
Infusion pump medication-dosage application softwareA software program intended to enable a healthcare professional to create, modify and store (manage) dosage parameters (protocols) for delivery of medication by an electronic infusion pump(s) or a syringe pump(s) which is used in a hospital/institution (e.g., IV pole mounted) or used for ambulatory purposes [also known as computerized ambulatory drug delivery (CADD)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830767898
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709198415BivonaST26GN30NGF103N2026-07-16
10887709198422BivonaST26GN55NSC102N2026-07-16
10887709198439BivonaST26GN45NGF098N2026-07-16
10887709198446BivonaHT26GS60NSC097N2026-07-16
10887709198453BivonaHU26GS70NSB104N2026-07-16
10887709198460BivonaSU26GN50NGF113N2026-07-16
10887709198477BivonaFT26GN35NGE112N2026-07-16
10887709198484BivonaAT26GS70NSC096N2026-07-16
10887709198163BivonaFU26GN40NGE068N2026-07-14
10887709198170BivonaFU26GN50NGC069S2026-07-14
10887709198187BivonaFT26GN60NSF067N2026-07-14
10887709198194BivonaSU26GN40NGF073N2026-07-14
10887709198200BivonaFU26GN40NGA064N2026-07-14
10887709198217BivonaFT26GN40NGF074N2026-07-14
10887709198224BivonaFT26GN45SSF075N2026-07-14
10887709198231BivonaFT26GN30NSE076N2026-07-14
10887709198248BivonaFT26GN40NSE077N2026-07-14
10887709198255BivonaFT26GN60NGF078N2026-07-14
10887709198262BivonaFP26GN35ASF079N2026-07-14
10887709198279BivonaFT26GN35NGE080N2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860006582012TigerConnect Alarm ManagementCritical AlertPHC2026-05-29
10885403519475BD AlarisCAREFUSION 303, INC.PHC2025-12-23
00887709127234LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2025-05-23
00887709127241LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2025-05-23
00811505030450Ivenix Infusion SystemFresenius Kabi AGPHC2024-12-06
20085412676610DOSE IQ SAFETY SOFTWAREBAXTER HEALTHCARE CORPORATIONPHC2024-08-23
10885403520020Alaris™ Guardrails™ Editor Software Kit, Model 8961CAREFUSION 303, INC.PHC2024-08-02
10885403519666BD Alaris™ System Manager 9601, SoftwareCAREFUSION 303, INC.PHC2024-06-19
00382905168017BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
00382905168024BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
60382905168033BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
10085412676613DOSE IQ SAFETY SOFTWAREBAXTER HEALTHCARE CORPORATIONPHC2024-04-22
00887709122802LifeShield Infusion Safety Software Suite - LifeShield DLMICU MEDICAL, INC.PHC2023-10-03
00887709122819LifeShield Infusion Safety Software Suite - LifeShield CDRICU MEDICAL, INC.PHC2023-10-03
00811505030443Ivenix Infusion SystemFresenius Kabi AGPHC2023-08-07
00811505030399Ivenix Infusion SystemFresenius Kabi AGPHC2023-07-19
00811050530399Ivenix Infusion SystemFresenius Kabi AGPHC2023-04-07
00085412676616DOSE IQ SAFETY SOFTWAREBAXTER HEALTHCARE CORPORATIONPHC2022-09-22
00811505030351Ivenix Infusion SystemFresenius Kabi AGPHC2022-09-07
10885403510472BD Alaris™ Infusion Adapter, SoftwareCAREFUSION 303, INC.PHC2022-08-12
10885403510489BD Alaris™ Calculation Services, SoftwareCAREFUSION 303, INC.PHC2022-06-09
04052682044106Vigilant Software SuiteFresenius Kabi AGPHC2022-05-20
15019517225471PharmGuardICU MEDICAL, INC.PHC2021-11-16
10885403896125Alaris™ Guardrails™ Editor Software Kit, Model 8961CAREFUSION 303, INC.PHC2021-10-08
10885403897535Alaris™ System Maintenance Software Kit, Model 8975CAREFUSION 303, INC.PHC2021-10-08
10885403960123AlarisCAREFUSION 303, INC.PHC2021-10-08
00811505030177Ivenix Infusion SystemFresenius Kabi AGPHC2021-06-25
00860006582005CommonPath EnterpriseCritical AlertPHC2021-04-22
50382905167015BD IntelliportBECTON, DICKINSON AND COMPANYPHC2020-09-30